WO2024038800A1 - 投与デバイス - Google Patents

投与デバイス Download PDF

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Publication number
WO2024038800A1
WO2024038800A1 PCT/JP2023/028899 JP2023028899W WO2024038800A1 WO 2024038800 A1 WO2024038800 A1 WO 2024038800A1 JP 2023028899 W JP2023028899 W JP 2023028899W WO 2024038800 A1 WO2024038800 A1 WO 2024038800A1
Authority
WO
WIPO (PCT)
Prior art keywords
administration device
guide member
pump member
pump
cylindrical
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2023/028899
Other languages
English (en)
French (fr)
Japanese (ja)
Inventor
俊志 治田
秀晶 三島
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shin Nippon Biomedical Laboratories Ltd
Original Assignee
Shin Nippon Biomedical Laboratories Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shin Nippon Biomedical Laboratories Ltd filed Critical Shin Nippon Biomedical Laboratories Ltd
Priority to KR1020257007855A priority Critical patent/KR20250050919A/ko
Priority to EP23854834.1A priority patent/EP4574190A1/en
Priority to JP2024541515A priority patent/JPWO2024038800A1/ja
Priority to CN202380059643.0A priority patent/CN119730896A/zh
Priority to AU2023327330A priority patent/AU2023327330A1/en
Publication of WO2024038800A1 publication Critical patent/WO2024038800A1/ja
Priority to MX2025001512A priority patent/MX2025001512A/es
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/08—Inhaling devices inserted into the nose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M13/00—Insufflators for therapeutic or disinfectant purposes, i.e. devices for blowing a gas, powder or vapour into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/006—Sprayers or atomisers specially adapted for therapeutic purposes operated by applying mechanical pressure to the liquid to be sprayed or atomised
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/02—Sprayers or atomisers specially adapted for therapeutic purposes operated by air or other gas pressure applied to the liquid or other product to be sprayed or atomised
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/003—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up
    • A61M15/0033—Details of the piercing or cutting means
    • A61M15/0035—Piercing means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/003—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up
    • A61M15/0033—Details of the piercing or cutting means
    • A61M15/0041—Details of the piercing or cutting means with movable piercing or cutting means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/003—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up
    • A61M15/0043—Non-destructive separation of the package, e.g. peeling
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B11/00—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use
    • B05B11/0005—Components or details
    • B05B11/0027—Means for neutralising the actuation of the sprayer ; Means for preventing access to the sprayer actuation means
    • B05B11/0029—Valves not actuated by pressure
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B11/00—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use
    • B05B11/0005—Components or details
    • B05B11/0027—Means for neutralising the actuation of the sprayer ; Means for preventing access to the sprayer actuation means
    • B05B11/0032—Manually actuated means located downstream the discharge nozzle for closing or covering it, e.g. shutters
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B11/00—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use
    • B05B11/01—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use characterised by the means producing the flow
    • B05B11/06—Gas or vapour producing the flow, e.g. from a compressible bulb or air pump
    • B05B11/061—Gas or vapour producing the flow, e.g. from a compressible bulb or air pump characterised by the means producing the gas or vapour pressure
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B11/00—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use
    • B05B11/01—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use characterised by the means producing the flow
    • B05B11/06—Gas or vapour producing the flow, e.g. from a compressible bulb or air pump
    • B05B11/062—Gas or vapour producing the flow, e.g. from a compressible bulb or air pump designed for spraying particulate material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0001—Details of inhalators; Constructional features thereof
    • A61M15/0021—Mouthpieces therefor
    • A61M15/0025—Mouthpieces therefor with caps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/06—Solids
    • A61M2202/064—Powder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/07—General characteristics of the apparatus having air pumping means
    • A61M2205/071—General characteristics of the apparatus having air pumping means hand operated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00—Methods of manufacture, assembly or production
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/06—Head
    • A61M2210/0618—Nose

Definitions

  • the present invention relates to an administration device, and more particularly to the structure of a single-use administration device for administering a predetermined amount of a substance to be administered, such as a powdered drug, into the nasal cavity or the like.
  • a treatment method in which powdered medicine is administered into the nasal cavity of patients with diseases such as rhinitis and nasal allergies.
  • a powdered drug filled in a capsule is administered into the nasal cavity using a special medication device.
  • drug administration devices used in this treatment method have been devised in the past (see, for example, Patent Documents 1 and 2).
  • the operation when administering a drug using such a drug dispensing device is generally as follows. That is, when the user removes the cap from the cylindrical member and inserts the tip into one nostril and presses the pump, air from the pump flows into the container such as a capsule through the air introduction passage, causing the air inside the container to flow. The drug is delivered into the user's nasal cavity for administration.
  • Blow molding which has a relatively low mold cost and is suitable for manufacturing hollow molded products, is exclusively used for pumps used in such drug dispensing devices.
  • an administration device with a novel structure that can uniformly eject and stably administer a substance to be administered, such as a powdered drug, no matter who uses it.
  • a single-use administration device for administering a predetermined amount of a substance to be administered, such as a powdered drug, into the nasal cavity or the like, comprising: a pump member that has a constricted overall shape and deforms when pressed to reduce its internal volume; a guide member disposed inside the pump member and guiding a deformable portion of the pump member;
  • a dispensing device comprising:
  • injection molding is one of the effective methods to replace blow molding, which has poor molding accuracy.
  • Injection molding has much better molding precision than blow molding, and it is possible to manufacture pumps with less variation in wall thickness, etc., and with less variation from product to product. Since it cannot be cut out, it cannot be manufactured by injection molding. In other words, if it is manufactured by injection molding, it must have a structure that can be cut out, such as a tapered shape that is gradually narrowed as a whole. However, if the pump has such a shape that is gradually constricted as a whole, it will not necessarily collapse straight when pressed, but will tilt to the side or bend in the middle, resulting in the pump collapsing uniformly. It's hard to become.
  • the guide member guides the deforming portion of the pump member, the pump member does not tilt or bend laterally during deformation. There's nothing to do.
  • the dispensing device of this embodiment which employs a pump member that can be manufactured by injection molding with excellent molding accuracy, and has a structure in which the deformed portion is guided by a guide member, it is possible to prevent the pump from collapsing when pressed. This makes it possible for the powdered medicine to be uniformly ejected and to be administered stably no matter who uses it.
  • the pump member may be formed with a stepped portion in which the degree of constriction changes in the middle of the constricted shape.
  • the pump member has a tapered large diameter portion and a tapered small diameter portion smaller in diameter than the large diameter portion, and the pump member has a tapered large diameter portion and a tapered small diameter portion smaller in diameter than the large diameter portion.
  • a stepped portion may be formed.
  • the pump member may have a circular cross section.
  • a pressed portion that is pressed by the user may be formed at the tip portion of the pump member where the outer diameter is the smallest.
  • the pump member may have a shape that can be molded by injection molding.
  • the cylindrical guide member may be arranged such that at least a portion thereof overlaps with the small diameter portion of the pump member.
  • the outer circumferential surface of the portion of the cylindrical guide member that overlaps with the small diameter portion of the pump member may be in contact with the inner circumferential surface of the small diameter portion.
  • a gap of 3 mm or less may be formed between the outer circumferential surface of the portion of the cylindrical guide member that overlaps with the small diameter portion of the pump member and the inner circumferential surface of the small diameter portion.
  • the cylindrical guide member is provided with a proximal cylindrical portion at the proximal end located at the end in the direction in which the pump member is pressed, and at the end facing the small diameter portion of the pump member.
  • the distal end portion located at may have a structure in which a distal end side cylindrical portion is connected and extends from the base end side cylindrical portion.
  • the outer diameter of the proximal cylindrical portion may be larger than the outer diameter of the distal cylindrical portion.
  • the outer peripheral surface of the proximal end of the cylindrical guide member located at the end in the direction in which the pump member is pressed is fixed in contact with the inner peripheral surface of the large diameter portion of the pump member. You can leave it there.
  • a plurality of proximal slits located along the circumferential direction may be provided at the proximal end of the cylindrical guide member.
  • a rod-shaped guide member may be provided on the inner peripheral side of the distal end of the pump member to suppress the lateral movement of the distal end when the pump member is deformed.
  • a guide hole may be provided in the center of the cylindrical guide member to guide the rod-shaped guide member so as to be slidable in the longitudinal direction thereof.
  • the rod-shaped guide member and the guide hole may be provided along the central axis of the administration device.
  • a guide hole may be formed inside the proximal end of the cylindrical guide member located at the end in the direction in which the pump member is pressed.
  • a plurality of distal slits located along the circumferential direction may be provided over at least a portion of the distal cylindrical portion of the cylindrical guide member.
  • the total width of the distal slits provided over at least a portion of the distal cylindrical portion may be 75% or less of the total circumferential length of the distal cylindrical portion.
  • the rod-shaped guide member may include a deformation suppressing portion that extends in a radial direction perpendicular to the shaft portion of the rod-shaped guide member and suppresses lateral movement when the pump member deforms.
  • the deformation suppressing portion may be formed in such a size and shape that at least a portion thereof is in contact with the inner circumferential surface of the distal end side cylindrical portion.
  • the deformation suppressing portion may be formed in a wing-like shape that spreads in a radial direction perpendicular to the shaft portion.
  • the tip portion of the rod-shaped guide member in the sliding direction may be flat, convex, concave, or tapered.
  • the above-described administration device includes a nozzle member having a filling space filled with a substance to be administered and an ejection opening from which the substance is sprayed, and a sealing member or a plug member sealing the opening of the filling space.
  • the tip portion of the rod-shaped guide member may be formed as a perforation portion for making a hole in the seal member or a plunger portion for pushing up and opening the plug member.
  • the above-mentioned dosing device has a structure in which a pump member is connected to the opening of the filling space of the nozzle member, and when the pump member contracts, air is sent out and the substance to be administered is ejected from the ejection opening of the nozzle member. There may be.
  • an administration device with a novel structure that can uniformly eject and stably administer a substance to be administered, such as a powdered drug, no matter who uses it.
  • FIG. 1 is a perspective view showing the appearance of a powdered drug administration device according to an embodiment of the present invention.
  • FIG. 2 is a perspective view showing the external appearance of the powdered drug administration device with the tab broken off during use.
  • FIG. 2 is a perspective view showing the external appearance of a powdered medicine administration device in a state in which powdered medicine is ejected.
  • FIG. 1 is an exploded perspective view of a powdered drug administration device.
  • FIG. 3A is a perspective view showing an example of the pump member
  • FIGS. 3B to 3E are perspective views showing other examples of the pump member. It is a side view explaining the characteristic of the shape of a pump member.
  • A A perspective view showing an example of a cylindrical guide member, and (B) a perspective view showing a pump member with the cylindrical guide member disposed inside.
  • FIG. 2 is a perspective view showing an example of a rod component (rod-shaped guide member) provided with a pointed piercer part (perforation part) and a wing-shaped part (deformation suppressing part).
  • FIG. 1 A longitudinal cross-sectional view showing the internal structure of the powdered drug administration device when the pump member is further pressed
  • FIG. 2 is a perspective view showing an example of a rod component (rod-shaped guide member) provided with a pointed piercer part (perforation part) and a wing-shaped part (deformation suppressing part).
  • FIG. 7 is a vertical cross-sectional view showing the state when further pressed.
  • FIG. 6 is a vertical cross-sectional view showing the internal structure of the powdered drug administration device in the case where (A) the rod component (rod-shaped guide member) has a wing-like part (deformation suppressing part) and (B) when there is no wing-like part.
  • FIGS. 3A to 3E each show examples of the shape of a rod component (rod-shaped guide member) provided with a pointed piercer part (punching part).
  • FIG. 6 is a diagram schematically showing, in order of (A) and (B), the movement of a rod component (rod-shaped guide member) provided with a pointed piercer portion (perforation portion) when the pump member is pressed.
  • FIG. 3 is a perspective view showing (A) a cylindrical guide member, (B) a rod component having a planar tip (bar-shaped guide member), and (C) a state in which these are combined. It is a side view showing an example of arrangement of a pump member and a cylindrical guide member. It is a side view showing an example of a cylindrical guide member.
  • FIGS. 3A and 3B are diagrams respectively showing examples of the configuration of a cylindrical guide member in which a distal end side slit is formed.
  • FIGS. 3A to 4C are diagrams each showing, for reference, an example of a pump member that did not collapse as intended in a conventional powder medicine administration device that does not include a cylindrical guide member.
  • a nasal administration device 10 for administering a powdered drug into the nasal cavity delivers a predetermined amount of powdered drug to a patient.
  • This device is suitable as a single-use type (one-time use type) for administering medicine into the nasal cavity of a patient.
  • the powdered drug administration device 10 of this embodiment includes a pump member 20, a cylindrical guide member 30, a rod component (rod-shaped guide member) 40, a nozzle member 50, a seal member 60, a tab (closing member) 70, etc. (Fig. 1 to Figure 4, etc.).
  • the pump member 20 is a member that sends out air to eject the powdered drug M, which is the object to be administered, from the ejection opening 54 of the nozzle member 50 when the powdered drug administration device 10 is used.
  • the pump member 20 has a structure in which the pump member 20 is crushed and its internal volume is reduced when the user (hereinafter also referred to as the user) pushes the pressed portion 29 at the bottom with a finger. (See Figure 3, etc.)
  • the posture of the powdered drug administration device 10 during use is not strictly limited, it is usually assumed that the device is used with the ejection opening 54 of the nozzle member 50 facing upward. ing.
  • the position in which the jetting opening 54 of the nozzle member 50 is directed vertically upward is set as the usage position for convenience, and in this position, the direction in which the jetting opening 54 of the nozzle member 50 is located is "upward". '', and the opposite is positioned as ⁇ lower'', and will be explained below (see Figure 3, etc.).
  • the specific shape of the pump member 20 is not particularly limited as long as it functions as described above.
  • the present embodiment employs a pump member 20 having a shape that can be molded by injection molding.
  • many of the pump members used in such powdered drug administration devices have been blow molded products with poor molding precision, but if they are injection molded, the molding precision is far superior to blow molding. Therefore, it is possible to realize a pump member with little variation in wall thickness, etc., and with little variation from product to product.
  • the diameter of the opening 25 needs to be larger than the diameter of other parts so that the mold can be cut out along the central axis 20C after molding.
  • the tip part (hereinafter also referred to as the bottom part) 24 side located at the bottom part in the usage posture is closed, and the opposite side is open as the opening part 25.
  • a pump member 20 having a tapered shape that is gradually narrowed is employed (see FIG. 5(A), FIG. 6, etc.).
  • This pump member 20 has a large diameter portion 21, a small diameter portion 22, a constricted portion (stepped portion) 23, a bottom portion 24, and an opening portion 25.
  • the large diameter portion 21 is a portion of the pump member 20 that is crushed and deformed and has a large diameter.
  • the large diameter portion 21 of this embodiment is formed in a tapered shape whose diameter gradually decreases from the opening 25 toward the bottom 24 (in FIG. 6, the thick dashed line indicating the degree of constriction of the large diameter portion 21 is reference).
  • the small diameter portion 22 is a portion of the pump member 20 that is smaller in diameter than the large diameter portion 21 in a portion that collapses and deforms.
  • the small diameter portion 22 of this embodiment is formed in a tapered shape whose diameter gradually decreases toward the bottom portion 24 (see the broken line indicating the degree of constriction of the small diameter portion 22 in FIG. 6).
  • the constricted portion 23 is formed as a portion where the degree of constriction changes in the middle of the pump member 20, which has a constricted shape as described above.
  • a constricted part 23 is formed between the large diameter part 21 and the small diameter part 22, and the degree of constriction is greater than that of the large diameter part 21 and the small diameter part 22 (larger inclination with respect to the central axis 20C). (See Figure 6, etc.)
  • the bottom portion (tip portion) 24 is the tip portion of the tapered small diameter portion 22 of the part of the pump member 20 that collapses and deforms, and is formed into a constricted shape such as a dome shape, for example. (See Figure 6, etc.)
  • the bottom 24 is in a state facing downward and serves as a cover for the user to press while placing his/her thumb during use. It functions as a pressing portion 29 (see FIG. 3, etc.).
  • the user hooks the index finger and middle finger on the finger hooks 56 and 57 arranged to sandwich the nozzle section 51, and presses the pressed section 29 of the bottom section 24 with the thumb.
  • a common usage mode is to eject the powdered medicine M from the ejection opening 54 of the nozzle member 50 by pressing.
  • the opening 25 is a portion of the pump member 20 that is crushed and deformed and becomes the opening of the large diameter portion 21 (see FIG. 6, etc.).
  • the part of the pump member 20 that is crushed and deformed that is, the tapered part from the opening 25 to the bottom part 24, is formed into a conical shape with a circular cross section in this embodiment, but this is preferable. This is just one example, and other shapes are also possible.
  • the pump member 20 in the powdered drug administration device 10 of this embodiment is further provided with a base portion 26 (see FIGS. 6, 7, etc.).
  • the base portion 26 has the same shape (e.g., elliptical shape) as a nozzle member 50, which will be described later, and is formed so as to be integrated with the nozzle member 50 to constitute the casing of the powdered drug administration device 10. (See Fig. 4, Fig. 5(A), etc.).
  • the portions of the pump member 20 that are crushed and deformed (the large diameter portion 21, the small diameter portion 22, the constricted portion 23) and the base portion 26 are integrally molded.
  • the pump member 20 may be constructed by molding the portion 26 separately and then integrating the pump member 20 by welding a portion thereof or the like.
  • the base portion 26 may have a different shape depending on the shape of the nozzle member 50 (see FIGS. 5(B), (E), etc.), or may further include a pump cover 26c. (See FIGS. 5(C) and 5(D)).
  • the pump cover 26c prevents the deformed portion of the pump member 20 from being accidentally crushed or the powdered medicine M from being squirted out before use, and also prevents the distal end portion 24 of the pump member 20 from being pushed upward.
  • the pump cover 26c is not provided on the front side (or back side) of the pump member 20, so that the user can push the bottom part 24 with a finger (mainly the thumb). 24 may be provided with a dish-shaped portion 24d that widens the contact area of the user's finger (see FIG. 5(B)).
  • the cylindrical guide member 30 is a member that is arranged inside the pump member 20 described above and is provided to guide a portion of the pump member 20 that is deformed.
  • the specific structure of the cylindrical guide member 30 is not particularly limited as long as it has the function of guiding the part in this way.
  • a substantially cylindrical member with open ends is arranged inside the pump member 20 and used as the cylindrical guide member 30 (see FIG. 4, etc.).
  • This cylindrical guide member 30 is integrated into the nozzle member 50 by fitting the base end 31 thereof.
  • the cylindrical guide member 30 is arranged such that at least a portion thereof overlaps with the small diameter portion 22 of the pump member 20.
  • the cylindrical guide member 30 in the powdered drug administration device 10 of this embodiment is provided so that at least a portion of its lower end 32 overlaps the small diameter portion 22 of the pump member 20 (FIGS. 8 and 11). , see Figure 22, etc.).
  • the portion of the outer circumferential surface 33 of the cylindrical guide member 30 that overlaps with the small diameter portion 22 of the pump member 20 may be in contact with the inner circumferential surface 22i of the small diameter portion 22, but does not necessarily have to be in contact with the inner circumferential surface 22i. It may be separated from the peripheral surface 22i.
  • the size of the gap between the outer peripheral surface 33 of the cylindrical guide member 30 and the inner peripheral surface 22i of the small diameter portion 22 is determined by the size of the gap between the cylindrical guide that guides the deforming portion of the pump member 20. It is preferable that the thickness be less than a predetermined value (for example, 3 mm or less) so that the function of the member 30 can be fully exhibited.
  • a guide hole 34 is provided in the central portion 30C of the cylindrical guide member 30 to guide the rod component (bar-shaped guide member) 40 in a state where it can slide along its longitudinal direction (FIGS. 4 and 9). etc.).
  • the guide hole 34 in the powdered drug administration device 10 of this embodiment is provided so as to extend along the central axis (indicated by reference numeral 10C in FIG. 4) of the powdered drug administration device 10.
  • a locking portion 34f for locking the rod component 40 at a predetermined position is formed on the inner wall 34i of the guide hole 34 (see FIG. 16, etc.).
  • the locking portion 34f is formed to be slightly smaller than the diameter of the edge portion 44e (see FIG. 15(E), etc.), which is the maximum diameter of the pointed piercer portion 44 of the rod component 40 (see FIG. 16(E)). B) etc.). Until the powdered drug administration device 10 is used, the edge 44e of the pointed piercer portion 44 is locked to the locking portion 34f, and the rod component 40 remains in a predetermined position. (See Figure 16).
  • the rod component 40 is a rod-shaped guide member provided on the inner circumferential side of the bottom portion 24 of the pump member 20, and includes a shaft portion 42 that extends linearly. (see Fig. 4, Fig. 8, etc.).
  • the lower end portion 43 of the rod component 40 is attached near the center of the bottom portion 24 of the pump member 20 so that the rod component 40 is vertical.
  • the rod part 40 is attached to the pump member 20 by inserting the lower end part 43 having a smaller diameter than the shaft part 42 into the boss part 24b formed on the bottom part 24 of the pump member 20 (see FIG. reference).
  • the powdered drug administration device 10 including such a rod component 40
  • the bottom portion (tip portion) 24, small diameter portion 22, etc. may move laterally. is suppressed and pushed straight up.
  • the powdered drug administration device 10 a uniform operation in which the pump member 20 is pushed straight up can be realized no matter who uses it.
  • the upper end portion 41 of the rod component 40 (the tip portion in the direction in which the pump member 20 slides when pressed) can have various shapes depending on the purpose, such as a flat surface, a convex shape, a concave shape, or a tapered shape.
  • the rod component 40 in the powdered drug administration device 10 of this embodiment has a tapered upper end 41 and a pointed piercer 44 with a pointed end (see FIG. 4, etc.). ).
  • the rod part 40 with the pointed piercer part 44 formed at the end in this way can be used as a piercer, in which the pointed piercer part 44 of the upper end part 41 makes a hole in the sealing member 60 when the pump member 20 is pressed. (See FIGS. 9, 13, 16 to 19, etc.).
  • FIG. 9 etc. show the rod component 40 whose upper end part 41 is conical, this is only a suitable example.
  • the upper end portion 41 may have a conical shape (see FIGS. 15(B) and 15(E)), or a cross section with grooves 42C formed on all sides.
  • the cone-like shape formed on the shaft portion 42 of the shape see FIG. 15(D)
  • there are also shapes with an elliptical inclined surface see FIG. 15(C)
  • half-shaped shapes with different directions of inclination It may also have a shape having two elliptical inclined surfaces and two points (see FIG. 15(A)).
  • the nozzle member 50 is a member equipped with a nozzle portion 51 that facilitates administering the powdered medicine M into the patient's nasal cavity.
  • the nozzle portion 51 is appropriately rounded near its tip as necessary (see FIGS. 4, 8, etc.).
  • a filling space 52 filled with powdered medicine M is formed inside the nozzle member 50 (see FIG. 8(A), etc.).
  • An ejection opening 54 for ejecting the powdered medicine M is provided (see FIG. 2, etc.).
  • An opening 53 is formed on the base end side of the nozzle member 50 (the side attached to the pump member 20 side), through which the powdered medicine M can be filled into the filling space 52 (see FIG. 8, etc.).
  • the nozzle member 50 is provided with finger hooks 56 and 57 arranged to sandwich the nozzle portion 51 (see FIG. 4, etc.).
  • the seal member 60 is a member that seals the opening 53 of the filling space 52 of the nozzle member 50 (see FIGS. 3B and 3C).
  • the sealing member 60 is a moisture-proof film (for example, an aluminum sheet) that seals the filling space 52 and prevents the powdered medicine M from deteriorating due to air and moisture, and is easy to pierce with the pointed piercer part 44 during use. It is preferable to use a member.
  • the present embodiment employs a sealing member 60 that maintains airtightness or sealing performance without tearing or peeling off even if the internal pressure of the pump member 20 rises to a predetermined level.
  • the tab 70 is a member that closes the ejection opening 54 of the nozzle member 50.
  • the tab 70 of this embodiment is attached to the tip of the nozzle member 50 in a breakable state, and when in use, the user breaks off the tab 70 by hand to open the ejection opening 54. (See Figures 1, 2, etc.).
  • the pump member 20 is connected to the opening 53 of the filling space 52 of the nozzle member 50 (see FIG. 8, etc.), and the pump member 20 is crushed to contract.
  • the structure is such that air is sent out along with the operation to eject the powdered medicine M from the ejection opening 54 of the nozzle member 50 (see FIG. 13, etc.).
  • the powdered drug administration device 10 according to the present embodiment includes a pump member 20 having a shape in which a large diameter portion 21 and a small diameter portion 22 are connected via a constricted portion 23, and a pressed portion 29 of a tip portion 24. It tends to collapse when pressed.
  • the pump member 20 having such a shape is easily crushed as intended along the central axis 20C when the pressed portion 29 is pressed.
  • the powdered drug administration device 10 of the present embodiment in which such a pump member 20 is molded by injection molding with excellent molding accuracy, there is little variation in the wall thickness of the pump member 20, and errors from product to product are small. As intended, all products are equally susceptible to crushing.
  • the powdered drug administration device 10 of this embodiment includes the cylindrical guide member 30 that guides the deformable portion of the pump member 20, the way the pump member 20 collapses when pressed is uniform. This makes it possible for the powdered medicine M to be uniformly ejected and administered stably no matter who uses it.
  • the entire rod component 40 may enter the guide hole 34, or a portion of the rod component 40 may
  • the slidable length of the rod component 40 is the length up to when it abuts against the end 37e of the inner cylindrical portion 37 constituting the guide hole 34 (see FIG. 10).
  • the amount of collapse of the pump member 20 corresponding to the slidable length of the rod component 40 in other words, the maximum amount of deformation along the central axis 10C of the pressed pump member 20 is "S" (see Figure 11).
  • the rod component 40 of the powdered drug administration device 10 not only inhibits lateral movement of the rod component 40 when the pump member 20 is deformed, but also assists in pushing the rod component 40 straight up.
  • the device may further include a deformation suppressing portion.
  • a powdered drug administration device 10 including such a deformation suppressing portion will be described as a second embodiment of the present invention (see FIGS. 12, 13, etc.). Note that the following description will focus on parts of the configuration that are different from the first embodiment described above.
  • the rod component 40 of the powdered drug administration device 10 of this embodiment includes four wing-shaped deformation suppressing parts (hereinafter also referred to as wing parts) 45 that extend radially from the shaft part 42 (see FIG. 12, etc.). ).
  • the wing-shaped portion 45 of the present embodiment is formed in a size and shape in which at least a portion thereof (for example, the outer peripheral edge portion 45e) is in contact with the inner peripheral surface of the distal end side cylindrical portion 36 of the cylindrical guide member 30. This is a preferred example, and may be formed in such a size and shape that a predetermined gap is formed between it and the inner circumferential surface of the distal end side cylindrical portion 36.
  • the wing-shaped portion 45 functions as a means for suppressing deformation in the event of incorrect operation of the pump, so that the pump member 20 is pushed from the side. In addition to preventing crushing, in conjunction with other functions, it is further possible to push the rod component 40 straight up (see FIGS. 13 and 14(A)).
  • a conventional powdered drug administration device 10' that is not provided with such a wing-shaped portion, there is a possibility that the pump member 20' may be crushed when an external force is unexpectedly applied (Fig. 14 (See (B).
  • FIG. 14(B) and FIG. 28 the symbols of members corresponding to the above-described powdered drug administration device 10 are shown with a dash (') added thereto).
  • the wing-shaped portion 45 can support the rod component 40 to be pushed straight up as necessary, primarily to prevent the pump member 20 from being unintentionally deformed when the pump is erroneously operated.
  • the wing-shaped portion 45 is shown extending radially from the shaft portion 42, but this is only a suitable example (see FIG. 12, etc.).
  • the wing-shaped portion 45 may be formed in a shape that is curved or bent in the middle when viewed from above (or when viewed from the bottom) along the central axis 10C.
  • the proximal end of the cylindrical guide member 30 (the end located at the end in the direction in which the pump member 20 is pressed), In the case of the drug administration device 10, the upper end corresponds to the upper end, so it will be described as the "upper end” below.)
  • An inner cylindrical part 37 that constitutes the guide hole 34 is formed inside the guide hole 34 (see FIG. 25, etc.). ).
  • the inner cylindrical portion 37 is configured to extend from the proximal cylindrical portion 35 of the cylindrical guide member 30 or at least a portion of the distal cylindrical portion 36 from the proximal cylindrical portion 35 by cross-shaped beams 37b that extend radially in all directions. connected across.
  • the outer cylindrical portion 38 is arranged so that at least a portion thereof overlaps from a portion of the large diameter portion 21 of the pump member 20 to a portion of the small diameter portion 22 across the constriction portion 23 in a side view. (See Figure 22).
  • the outer cylinder portion 38 of the cylindrical guide member 30 provided in this way guides the deforming portion of the pump member 20 so that the portion collapses straightly and uniformly.
  • a slit may be formed on the distal end side of the outer cylinder portion 38.
  • a plurality of distal slits 36c are provided in at least a portion of the distal cylindrical portion 36 of the cylindrical guide member 30, which are positioned along the circumferential direction (see FIG. 26). Providing such a distal end side slit 36c can be expected to reduce the weight of the cylindrical guide member 30 and simplify its shape. It is preferable that the tip side slits 36c are provided at equal intervals in the circumferential direction (see FIG. 26(A)).
  • the total length of the width of the distal slit 36c in the circumferential direction is equal to or less than a predetermined ratio of the total circumferential length at the lower end 32 of the distal cylindrical portion 36, For example, it is preferably 75% or less. This means that even if the portions other than the distal end slit portion 36c are, for example, less than 25%, which is relatively weak in physical structure, they are uniformly arranged along the circumferential direction of the distal cylindrical portion 36.
  • the deformable portion of the pump member 20 is crushed as intended, it can fully fulfill its role as a guide member that creates a hook that guides the deformable portion of the pump member 20 to collapse as intended.
  • the plurality of distal end side slits 36c are uniformly arranged along the circumferential direction.
  • the tip side slit 36c may have a form other than a slit shape, for example, a form formed by a space between a plurality of bracket-like rib portions 38r arranged in the circumferential direction (FIG. 26(B). )reference).
  • the proximal cylindrical portion 35 of the cylindrical guide member 30 may be provided with a plurality of proximal slits 35s located along the circumferential direction (see FIGS. 24(A) to 24(D). , in FIG. 24(A), the proximal end side slit 35s is shown by an imaginary line).
  • the total width of the proximal slits 35s along the circumferential direction is equal to or less than a predetermined ratio, for example, 50% or less, of the total circumferential length of the upper end portion 31 of the cylindrical guide member 30. It is preferable that there be.
  • the portion other than the proximal slit 35s is, for example, about 50%, which is relatively weak in physical structure, it must be uniformly arranged along the circumferential direction of the distal cylindrical portion 36.
  • the proximal cylindrical portion 35 including the proximal slit 35s can function sufficiently to be fixed in contact with the inner circumferential surface 21i of the large diameter portion 21 of the pump member 20.
  • the plurality of base end side slits 35s are uniformly arranged along the circumferential direction.
  • a cylindrical portion in this specification, a portion shown as a proximal cylindrical portion 35 and can also be referred to as an upper end cylindrical portion
  • a cylindrical guide member 30 having a structure in which a portion (in this specification, this portion is shown as a distal end cylindrical portion 36 and can also be referred to as a lower end cylindrical portion) is connected may be adopted (see FIG. 23).
  • the cylindrical guide member 30 of this embodiment has a shape in which the outer diameter of the proximal cylindrical portion 35 is larger than the outer diameter of the distal cylindrical portion 36 (see FIG. 23, etc.).
  • the cylindrical guide member 30 may be formed such that the outer circumferential surface of the upper end portion 31 is fixed in contact with the inner circumferential surface 21i of the large diameter portion 21 of the pump member 20 (see FIG. 22).
  • an annular groove (not shown) is provided on the inner circumferential surface 21i of the large diameter portion 21 of the pump member 20, and an annular groove (not shown) is provided on the outer circumferential surface of the upper end portion 31 of the cylindrical guide member 30 so as to engage with this groove.
  • An annular convex portion 31t that protrudes outward is provided (see FIG. 22, etc.), and by engaging the annular convex portion 31t with the groove, the pump member 20 and the cylindrical guide member 30 are positioned relative to each other and are prevented from coming off. It can also be fixed.
  • the rod component 40 has a tapered upper end portion 41, but below, as a fourth embodiment of the present invention, the rod component 40 has a flat upper end portion 41. This will be explained using an example (see FIG. 20, FIG. 21, etc.).
  • the powdered drug administration device 10 of this embodiment is provided with a filling space 52 filled with the powdered drug M and a plug member 80 that seals the opening 53 of the filling space 52 (FIG. 20 reference). It is preferable that the plug member 80 has a shape that does not easily come out of the opening 53 until it is pressed with a suitable force, such as a spherical shape (see FIG. 20(A)) or a truncated conical shape (see FIG. 20(C)). be.
  • the opening 53 is formed to match the shape and size of the plug member 80.
  • the rod component 40 in the powdered drug administration device 10 of this embodiment has a flat upper end 41, this is only an example.
  • the upper end 41 of the rod component 40 may have any shape as long as it can open or open the opening 53 by pushing up the plug member 80 from below.
  • it may have a concave shape so as to be in full contact with the surface of the spherical plug member 80.
  • the powdered drug administration device 10 as described above is suitable as a device for administering nasal drugs, its use is not particularly limited thereto.
  • nasal administration was mainly used for local treatment, mainly to treat rhinitis, but recently drugs that are expected to have systemic effects, such as drugs that alleviate migraine and cancer pain, have been administered to the nasal mucosa.
  • the applications of the powdered drug administration device 10 include such drugs.
  • research is being conducted to transfer drugs from the olfactory area in the nasal cavity to the brain, and applications of the powdered drug administration device 10 include delivering nasal drugs to the olfactory area in the nasal cavity.
  • biopharmaceuticals that require strict dosage control and strict storage management is becoming more active, and the need for nasal application of these drugs is also increasing. It also includes usage.
  • An administration device comprising: [Additional note 2] The administration device according to supplementary note 1, wherein the pump member is formed with a stepped portion in which the degree of constriction changes in the middle of the constricted shape.
  • the pump member has a tapered large diameter portion and a tapered small diameter portion smaller in diameter than the large diameter portion, and the stepped portion is between the large diameter portion and the small diameter portion.
  • the administration device of claim 2 wherein the administration device is [Additional note 4] 4.
  • [Additional note 5] 5.
  • the administration device according to any one of Supplementary Notes 1 to 4, wherein a pressed portion to be pressed by a user is formed at a tip portion of the pump member having the smallest outer diameter. [Additional note 6] 6.
  • the administration device according to any one of appendices 1 to 5, wherein the pump member has a shape that can be molded by injection molding.
  • the cylindrical guide member is arranged such that at least a portion thereof overlaps with the small diameter portion of the pump member.
  • an outer circumferential surface of a portion of the cylindrical guide member that overlaps with the small diameter portion of the pump member is in contact with an inner circumferential surface of the small diameter portion.
  • a gap of 3 mm or less is formed between the outer circumferential surface of the portion of the cylindrical guide member that overlaps with the small diameter portion of the pump member and the inner circumferential surface of the small diameter portion.
  • Administration device [Additional note 10]
  • the cylindrical guide member is provided with a proximal cylindrical portion at a proximal end located at an end in a direction in which the pump member is pressed, and is located at an end facing the small diameter portion of the pump member.
  • the administration device according to any one of claims 7 to 9, wherein the distal end portion has a structure in which a distal cylindrical portion is connected and extends from the proximal cylindrical portion.
  • nozzle member having a filling space filled with the substance to be administered and a jetting opening from which the substance to be administered is ejected, and a sealing member or a plug member sealing the opening of the filling space, 18.
  • the administration device according to any one of Supplementary Notes 15 to 17, wherein the distal end portion of the rod-shaped guide member is formed as a perforation portion for making a hole in the sealing member or a plunger portion for pushing up and opening the plug member.
  • the pump member is connected to the opening of the filling space of the nozzle member, and the pump member sends out air as the pump member contracts to eject the substance from the ejection opening of the nozzle member. 26.
  • the present invention is suitable for application to various drug administration devices for nasal passages and the like.
  • 10,10'...Powdered drug administration device (administration device) 10C...Central axis 20, 20'...Pump member 21...Large diameter portion 21i...Inner circumferential surface of large diameter portion 22...Small diameter portion 22i...Inner circumferential surface of small diameter portion 23...Constricted portion (stepped portion) 24...Bottom (tip) 24b...Boss part 24d...Dish-shaped part 25...Opening part 26...Base part 26c...Pump cover 29...Pressed part 30...Cylindrical guide member (30C...Central part) 31...

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Mechanical Engineering (AREA)
  • Otolaryngology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
PCT/JP2023/028899 2022-08-17 2023-08-08 投与デバイス Ceased WO2024038800A1 (ja)

Priority Applications (6)

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KR1020257007855A KR20250050919A (ko) 2022-08-17 2023-08-08 투여 디바이스
EP23854834.1A EP4574190A1 (en) 2022-08-17 2023-08-08 Administration device
JP2024541515A JPWO2024038800A1 (https=) 2022-08-17 2023-08-08
CN202380059643.0A CN119730896A (zh) 2022-08-17 2023-08-08 投放器具
AU2023327330A AU2023327330A1 (en) 2022-08-17 2023-08-08 Administration device
MX2025001512A MX2025001512A (es) 2022-08-17 2025-02-06 Dispositivo de administracion

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS613985U (ja) * 1984-06-14 1986-01-11 株式会社 ゼツト工業 ポンプ
JPH09253208A (ja) 1996-03-21 1997-09-30 Unisia Jecs Corp 鼻腔用投薬器
JP2002505981A (ja) * 1998-03-10 2002-02-26 バルワー エス．アー． 格納容器、格納容器の充填方法、そして、格納容器に格納された流体製品を投与する装置
JP2004510559A (ja) 2000-10-12 2004-04-08 ベスパック・パブリック・リミテッド・カンパニー 投薬装置
JP2016523647A (ja) * 2013-07-05 2016-08-12 アプター フランス エスアーエス 流体又は粉末ディスペンサー装置
WO2019054121A1 (ja) * 2017-09-15 2019-03-21 株式会社新日本科学 薬剤保管用のノズル付きカートリッジとその噴射器、および鼻腔用粉状薬剤施薬装置

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009253208A (ja) 2008-04-10 2009-10-29 Elpida Memory Inc 半導体記憶装置及びその製造方法

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS613985U (ja) * 1984-06-14 1986-01-11 株式会社 ゼツト工業 ポンプ
JPH09253208A (ja) 1996-03-21 1997-09-30 Unisia Jecs Corp 鼻腔用投薬器
JP2002505981A (ja) * 1998-03-10 2002-02-26 バルワー エス．アー． 格納容器、格納容器の充填方法、そして、格納容器に格納された流体製品を投与する装置
JP2004510559A (ja) 2000-10-12 2004-04-08 ベスパック・パブリック・リミテッド・カンパニー 投薬装置
JP2016523647A (ja) * 2013-07-05 2016-08-12 アプター フランス エスアーエス 流体又は粉末ディスペンサー装置
WO2019054121A1 (ja) * 2017-09-15 2019-03-21 株式会社新日本科学 薬剤保管用のノズル付きカートリッジとその噴射器、および鼻腔用粉状薬剤施薬装置

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JPWO2024038800A1 (https=) 2024-02-22
MX2025001512A (es) 2025-05-02
EP4574190A1 (en) 2025-06-25
CN119730896A (zh) 2025-03-28
KR20250050919A (ko) 2025-04-15
AU2023327330A1 (en) 2025-02-27

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